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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019982
Receipt No. R000023072
Scientific Title The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery: a double-masked, placebo-controlled, randomized clinical trial
Date of disclosure of the study information 2015/11/29
Last modified on 2017/11/25

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Basic information
Public title The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery: a double-masked, placebo-controlled, randomized clinical trial
Acronym The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery
Scientific Title The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery: a double-masked, placebo-controlled, randomized clinical trial
Scientific Title:Acronym The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery
Region
Japan

Condition
Condition Breast cancer surgery
Classification by specialty
Breast surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The postoperative analgesic effect of retrolaminar block
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of patients who need analgesics within 12 hours after surgery
Key secondary outcomes 1. The number of patients who need antiemetics within 12 hours after surgery

2. Numerical pain rating scores within 3 hours after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Single-shot retrolaminar block with total 30mL of 0.5% ropivacaine
Interventions/Control_2 Single-shot retrolaminar block with total 30mL of normal saline
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. ASA physical status 1 - 2
2. Under general anesthesia
3. Breast cancer surgery with axillary lymph node dissection
Key exclusion criteria 1. Estimated glomerular filtration rate < 60 mL / min / 1.73 * square meter
2. NYHA classification > II
3. Hugh-Jones classification > II
3. Active phase peptic ulcer
4. BMI < 15 or BMI >= 35
5. Skin lesion at a block site
6. Allergies to local anesthetics, pentazocine or NSAIDs
7. Past history of severe postoperative nausea and vomiting
Target sample size 150

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Mamoru Murakami
Organization Tohoku Kosai Hospital
Division name Department of anesthesiology
Zip code
Address 2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL +08-22-227-2211
Email masuiker@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Mamoru Murakami
Organization Tohoku Kosai Hospital
Division name Department of anesthesiology
Zip code
Address 2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL +08-22-227-2211
Homepage URL
Email masuiker@gmail.com

Sponsor
Institute Tohoku Kosai Hospital
Institute
Department

Funding Source
Organization Tohoku Kosai Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Tohoku Kosai Hospital (Miyagi)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2016 Year 05 Month 25 Day
Date of closure to data entry
2016 Year 05 Month 25 Day
Date trial data considered complete
2016 Year 07 Month 17 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 29 Day
Last modified on
2017 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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